a study of bl-b01d1+pd-1 monoclonal antibody in patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma and other solid tumors

Conditions: Non-small Cell Lung Cancer; Nasopharyngeal Carcinoma; Solid Tumor

Summary: this phase ii study is a clinical study to explore the efficacy and safety of bl-b01d1 combined with pd-1 monoclonal antibody in patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma and other solid tumors.


Eligibility criteria:
inclusion criteria: 1. sign the informed consent form voluntarily and follow the protocol requirements; 2. any gender; 3. age: ≥18 years old; 4. expected survival time for 3 months or more; 5. patients with locally advanced or metastatic non-small cell lung cancer or nasopharyngeal carcinoma confirmed by histopathology and/or cytology; 6. subjects were able to provide 6-10 slides of archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 2 years; 7. at least one measurable lesion meeting the recist v1.1 definition was required; 8. ecog 0 or 1; 9. the toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by nci-ctcae v5.0; 10. no serious cardiac dysfunction, left ventricular ejection fraction 50% or higher; 11. screening period not allowed within 14 days before a blood transfusion, are not allowed to use any cell growth factor, and/or liters of platelet medicine, organ function level must conform to the requirements; 12. coagulation function: international normalized ratio (inr) ≤1.5, and activated partial thromboplastin time (aptt) ≤1.5uln; 13. the urine protein + 2 or 1000 mg / 24 h or less or less; 14. for premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum or urine must be negative for pregnancy, and must be non-lactating; all enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment. exclusion criteria: 1. stage 1 egfr-sensitive mutant non-small cell lung cancer patients with systemic chemotherapy; stage 2 patients who had received previous systemic therapy; 2. in the second stage queue one signed informed consent before gene sequencing report suggests patients such as mutation of alk fusion; 3. anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose; mitomycin and nitrosoureas were administered within 6 weeks before the first dose; fluorouracil class oral drugs, etc.; 4. serious heart disease; 5. long qt, complete left bundle branch block, iii degree atrioventricular block; serious arrhythmia; 6. active autoimmune and inflammatory diseases; 7. before the first delivery within 5 years diagnosed as other malignant tumor; 8. two antihypertensive drugs poorly controlled hypertension; 9. patients with poor glycemic control; 10. with a history of ild, current ild or suspected suffering from such diseases during screening; 11. complicated with pulmonary diseases leading to severe respiratory function impairment; 12. there is a lot of serous cavity effusion, or have a serous cavity effusion and has symptoms, or poorly controlled serous cavity effusion patients; 13. imaging studies suggest tumor has violated or package around the chest, neck, pharyngeal large blood vessels; 14. unstable thrombotic events requiring therapeutic intervention within 6 months before screening; infusion-related thrombosis was excluded; 15. active central nervous system of patients; 16. for restructuring or human mouse chimeric antibody on study of humanized anti-platelet antibody has a history of allergies or allergic to bl - b01d1 any supplementary material composition of patients; 17. before transplant or allogeneic hematopoietic stem cell transplantation (allo - hsct); 18. human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis b virus infection or active hepatitis c virus infection; 19. active infection requiring systemic therapy; 20. subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 21. had participated in another clinical trial within 4 weeks before the first dose; 22. other conditions for trial participation were not considered appropriate by the investigator.